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Diabetes Mellitus, Type 2 With Acute Coronary SyndromNCT04354740

Predictors of Coronary Revascularization Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome

An observational study of Diabetes Mellitus, Type 2 With Acute Coronary Syndrom, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To explore the metabolic outcomes of PCI versus CABG in diabetic patients presented by ACS. To verify the diagnostic and prognostic value of speckle tracking echocardiography in early detection of MACE after ACS in diabetic patients treated by 2 modalities. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)
Type of treatment
Surgery or procedure
How many people
100 participants
Where
No sites listed yet
Study dates
Jul 2020to Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Adult

Study population: This study includes all patients (middle aged according to WHO 55 years of age) presented by ACS (STEMI , Non STEMI) Those patients are divided to: Group A : Diabetic Group B: Non diabetic Then each group is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study

Who may be able to join

  • This study includes all patients (middle aged according to WHO 55 years of age) presented by ACS (STEMI , Non STEMI) from July 2020 to June2021 in both CCU Of Internal Medicine Departemennt and and EL Orman Assiut University Hospital of Cardiology and Cardiothoracic Surgery.
  • ACS was defined and patients were managed according to the European Guidelines . Patients with acute chest pain and persistent (>20 min) ST-segment elevation, i.e., STEMI generally reflected an acute total coronary occlusion. All patients received immediate myocardial reperfusion treatment by primary coronary intervention and angioplasty or fibrinolytic therapy, as appropriate. Patients with acute chest pain but no persistent ST-segment elevation, referred to as Non-STEMI included transient ST-segment elevation, persistent or transient ST-segment depression ,T-wave inversion, flat T waves or pseudo-normalized T waves or completely normal ECG at admission. Thygesen, K.; etal.2019

Who cannot join

  • -Ranal disease ie stage 3,4 or on dialysis.
  • Advanced hepatic diseases ie(child B,C)
  • Poor echo window including morbid obesity.
  • Age >18 and more than 55 years old
  • Patients with previous history of significant valvular diseases,atrial fibrillation
  • EF less than 40%

Trial locations and contacts

No sites are listed yet.

Rabab E.A Mashhour, doctor contact

0201011277166

emadrabab6@gmail.com

About this study

  • To explore the metabolic outcomes of PCI versus CABG in diabetic patients presented by ACS.
  • To verify the diagnostic and prognostic value of speckle tracking echocardiography in early detection of MACE after ACS in diabetic patients treated by 2 modalities.
Read the detailed description

Diabetes mellitus (DM) doubles the risk of cardiovascular disease and about 75% of deaths in diabetic patients are due to coronary artery disease. Studies performed during the 1980's and 90's demonstrated increasing short and long-term mortality in diabetic patients undergoing CABG compared with non-diabetic patients. However, more recently, reports have shown a significant reduction in mortality among patients with diabetes. Alexander Kogan etal., 2018 Cardiac revascularization in patients with stable coronary artery disease (CAD) is an important therapeutic intervention for the improvement of symptoms and prognosis. Prior to revascularization, patients must receive guideline-recommended medical therapy due to its established benefits. Thomas Nyström etal.,2018 Also notable is that the best current revascularization results achieved with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES) and for coronary artery bypass grafting (CABG) with maximal use of arterial grafts. The multitude of studies for revascularization comparing PCI and CABG cannot provide a single solution for the entire spectrum of patients with stable CAD. Nevertheless, CABG results in more complete revascularization than PCI, particularly in complex multivessel CAD, which often is observed in patients with diabetes. Thomas Nyström etal., 2018 Approximately 25% of all patients who undergo multivessel revascularization have diabetes. A number of studies have demonstrated that CABG should be the preferred strategy for multivessel revascularization in patients with diabetes. In this group, CABG leads to improved survival rates and a reduced risk of myocardial infarction and repeat revascularization compared with revascularization with PCI. In the BARI (Bypass Angioplasty Revascularization Investigation) trial, a subset of 353 patients with diabetes who underwent PCI had almost a doubled 5-year mortality compared with those who underwent CABG. However, if only saphenous vein grafts were used as conduits, cardiac mortality was similar to that with PCI, demonstrating the importance of arterial grafting. It was further demonstrated in the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) study that among patients with diabetes, prompt revascularization by CABG significantly reduced major CV events compared with intensive medical treatment alone. In contrast, there was no difference in CV events between patients who underwent PCI and patients who received only intensive medical treatment.Thomas Nyström etal.,2018 Pathological left ventricular remodeling (LVR) was the common characteristic of most cardiovascular diseases. It clinically defined as the adverse changes in LV mass, volume, and geometry after myocardial injury, which could be considered to be an adaptive response to cardiac performance inadequacy and a marker of poor prognosis in patients with underlying LV dysfunction. In recent years, the impact of non hemodynamic factors on cardiac structure and function, such as obesity and other metabolic disorder, had been gradually valued. Van Bilsen et al even proposed a theory of "metabolic remodeling." This theory held that glycolipid metabolism disturbance could change the metabolic pathway of myocardial energy and finally lead to LV remodeling and dysfunction. Qingqing Wang etal.,2018 Myocardial strain quantification by speckle tracking echocardiography has been well validated. It is a validated and accurate measure of regional systolic LV function.It has also been shown to be superior to visual assessment of wall motion in detection and quantification of regional systolic function. Strain and other deformation parameters are sensitive tools for detection of ischemia. It is hypothesized that global and regional left ventricular2D strain by speckle tracking echocardiography (STE) facilitates an early and accurate non-invasive tool to predict the presence of acute coronary artery occlusion in patients with non ST-segment elevation myocardial infarction (NSTEMI). Viola William Keddeas,etal 2016

Being tested
with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)Procedure or surgery

    Also called coronary artery bypass grafting (CABG) with maximal use of arterial grafts

    II-PCI:

    -Coronary angiography and intervention will be done according to the European guidelines of ACS revascularization.

    III-CABG:

Study groups in NCT04354740
Study groupRoleWhat they receive
Group A : Diabeticgroup is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study
Receives: Procedure: with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)
Group B: Non diabeticgroup is subdivided into 2sub-groups: Group 1: Group: underwent PCI(Primary or Rescue) Group 2: underwent CABG Patients diagnosed as multivessel disease or left main coronary artery lesion will be included in the study
Receives: Procedure: with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiac events (MACEs)

    Rate of myocardial infarction (MI), Rate of revascularization, Rate of cerebrovascular events"stroke"

    Measured: 12 mounths

Secondary outcomes (1)
  1. In hospital mortality

    Rate of death (mortality rate)after CABG or PCI

    Measured: 12mounths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study startJul 2020 (estimated)
  3. Primary completionJun 2021 (estimated)
  4. Study completionJul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04354740
Sponsor's protocol ID
coronary revascularization,DM2
Status last verified
Apr 2020
First submitted
17 Apr 2020
Last updated
22 Apr 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Patel SA, Deepa M, Shivashankar R, Ali MK, Kapoor D, Gupta R, Lall D, Tandon N, Mohan V, Kadir MM, Fatmi Z, Prabhakaran D, Narayan KMV. Comparison of multiple obesity indices for cardiovascular disease risk classification in South Asian adults: The CARRS Study. PLoS One. 2017 Apr 27;12(4):e0174251. doi: 10.1371/journal.pone.0174251. eCollection 2017.

    PubMed 28448582
  • Lu H, Tang B, Zhou Y, Xu C, Bundhun PK, Tang Z, Bao H. Short-Term Versus Long-Term Adverse Cardiovascular Outcomes Post Percutaneous Coronary Intervention in Patients with Insulin-Treated Type 2 Diabetes Mellitus: A Simple Meta-Analysis. Diabetes Ther. 2019 Aug;10(4):1487-1497. doi: 10.1007/s13300-019-0656-9. Epub 2019 Jun 29.

    PubMed 31256352

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2 With Acute Coronary Syndrom, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rabab E.A Mashhour, doctor (0201011277166, emadrabab6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiac events (MACEs) (time frame: 12 mounths). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04354740, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.

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